- An AE is any untoward medical occurrence in a patient ("patient" is defined as any subject who has been enrolled in the study as evidenced by the subject having signed informed consent) or any unfavorable and unintended sign (for example, an abnormal laboratory finding), symptom, or disease that occurs during the course of the clinical investigation. The AE may or may not be considered as related to the investigational drug or device. All AE's should be recorded in the patient's chart and graded mild, moderate, or severe. All AE's shall be handled to the hospital procedures in force and as soon as possible passed down to the study coordinators, in case of fatality at least within 24h.